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TRANSCRIPT
Roche
2015 results
London, 28 January 2016
3
This presentation contains certain forward-looking statements. These forward-looking
statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’,
‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among
other things, strategy, goals, plans or intentions. Various factors may cause actual results to
differ materially in the future from those reflected in forward-looking statements contained in
this presentation, among others:
1 pricing and product initiatives of competitors;
2 legislative and regulatory developments and economic conditions;
3 delay or inability in obtaining regulatory approvals or bringing products to market;
4 fluctuations in currency exchange rates and general financial market conditions;
5 uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side-effects of pipeline or marketed products;
6 increased government pricing pressures;
7 interruptions in production;
8 loss of or inability to obtain adequate protection for intellectual property rights;
9 litigation;
10 loss of key executives or other employees; and
11 adverse publicity and news coverage.
Any statements regarding earnings per share growth is not a profit forecast and should not be interpreted to
mean that Roche’s earnings or earnings per share for this year or any subsequent period will necessarily
match or exceed the historical published earnings or earnings per share of Roche.
For marketed products discussed in this presentation, please see full prescribing information on our website
www.roche.com
All mentioned trademarks are legally protected.
4
Group Severin Schwan Chief Executive Officer
2015 performance
Outlook
5
2015: Targets fully achieved
6
Targets for 2015 FY 2015
Group sales growth1 Mid-single digit +5%
Core EPS growth1 Ahead of sales growth2 +7%
Dividend outlook Further increase dividend in Swiss francs3
(Payout ratio increased to 60% from 56%) CHF 8.10
1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014; 3 2015 dividend as proposed by the Board of Directors
7
• Cancer immunotherapy: Phase II lung (POPLAR, BIRCH), rolling filing initiated;
Phase II bladder (IMvigor 210), filed in US; 9 NMEs in clinical development
• Alecensa (alectinib): Approved in US, filed in EU
• Cotellic (cobimetinib): Approved in US and EU
• Venetoclax: Filing acceptance in R/R CLL including 17p del in US
• Gazyva: Phase III (GADOLIN) in R/R iNHL, filed in US and EU
• Emicizumab (ACE 910): Updated phase Ib, start of Phase III in inhibitors
• Ocrelizumab: Phase III in RMS (OPERA I/II) and PPMS (ORATORIO)
Growth
• Group sales +5%1 driven by HER2 franchise (+19%), Avastin (+9%),
Esbriet (n.m.), Actemra (+23%) and Professional Diagnostics (+8%)
Profit
Sales
• +7% Core EPS growth1,2 driven by strong underlying business
Innovation
Neuroscience
Oncology
Hematology
1 At constant exchange rates (CER); 2 Excluding sale of filgrastim rights in 2014
2015: Highlights
2015: Strong sales growth in both divisions
8 CER=Constant Exchange Rates
2015 2014
CHFbn CHFbn CHF CER
Pharmaceuticals Division 37.3 36.7 2 5
Diagnostics Division 10.8 10.8 0 6
Roche Group 48.1 47.5 1 5
Change in %
2015: Sales growth for fifth consecutive year
9
0% 0% 1%
4%
2%
6%
4%
6% 6%
4%
8%
7%
5%
4%
5%
6%
5%
7%
6%
4%
0%
2%
4%
6%
8%
10%
Q1
11
Q2
11
Q3
11
Q4
11
Q1
12
Q2
12
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
All growth rates at Constant Exchange Rates (CER)
2015: Strong sales growth in all regions
10
0
3
6
9
12
15
18
21
Japan International Europe US
Diagnostics
Pharma
CHFbn
+6%
+4% +5%
+6%
+2% +13%
0%
+1%
+5%
+3%
+5%
+7%
All growth rates are YoY at Constant Exchange Rates (CER)
Roche: Significantly advancing patient care
Recognition for innovation 2013-present
11
Rank Company #
1 Roche 11
2 BMS 8
3 Novartis 6
3 Merck 6
3 Pfizer 6
4 GSK 5
11 Breakthrough Therapy Designations
Year Molecule
2016 Venetoclax (AML)
Venetoclax + Rituxan (R/R CLL)
2015
Actemra (Systemic sclerosis)
Atezolizumab (NSCLC)
Venetoclax (R/R CLL 17p del)
Emicizumab/ACE 910 (Hemophilia A)
2014
Esbriet (IPF)
Lucentis (DR)
Atezolizumab (Bladder)
2013 Alectinib (2L ALK+ NSCLC)
Gazyva (1L CLL)
Source: http://www.focr.org/breakthrough-therapies as at 21 January 2016; CLL=Chronic Lymphocytic Leukemia; NSCLC=Non-
Small Cell Lung Cancer; IPF=Idiopathic Pulmonary Hypertension; DR=Diabetic Retinopathy
2015: Strong underlying Group Core operating
profit & margin
12 CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014
35.6%
37.7% 38.3%37.2%
36.4%
15.1
17.217.9 17.6
17.5
2011 2012 2013 2014 2015
+5% at CER (+7%*)
% of sales
CHFbn
(+0.7%*)
2015: Strong underlying Core EPS growth
13
12.30
13.49 14.27 14.29
13.49
2011 2012 2013 2014 2015
+4% at CER (+7%*)
All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014
CHF
2015: Dividend and payout ratio further increased
14 1 compound annual growth rate
8.10
31.9 34.5
38.8
44.8
48.6
51.6
55.3
54.5 54.7
56.0
60.0
0
1
2
3
4
5
6
7
8
9
10
1990 1992 1994 1996 1998 2000 2002 2004 2006 2008 2010 2012 2014
Dividend payout ratio (%) CHF
2015 payout ratio: 60.0%
Payout ratio calculated as dividend per share divided by Core earnings per share (diluted); 2015 dividend as proposed by the Board of Directors;
Note: For 1995, a special dividend was paid out to mark F. Hoffmann-La Roche’s 100th anniversary in 1996
2015: Core EPS growth bridge
15
one-time
filgrastim*
+3.7%
+2.9% +6.6%
Full Year 2015
figures as reported
Sales
+5.3%
Core EPS Core EPS
Full Year 2015
excl. filgrastim*
All growth rates at Constant Exchange Rates (CER); * Excluding sale of filgrastim rights in 2014
2015 performance
Outlook
16
2016 onwards: Significant launch activities
17 Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.
FDA Breakthrough
Therapy Designation
Oncology/
hematology Neuroscience Ophthalmology Immunology
Cotellic + Zelboraf
BRAFmut melanoma
Venetoclax
R/R CLL including 17p del
Ocrelizumab
RMS/ PPMS
Lebrikizumab
Severe Asthma
Emicizumab (ACE910)
Hemophilia A
Atezolizumab
2L+ lung and bladder cancer
Alecensa
2L ALK+ lung cancer
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Atezolizumab+Avastin+chemo
1L NSCLC
Gazyva
1L aNHL (GOYA)
Gazyva
1L iNHL (GALLIUM)
Gazyva
Refractory iNHL (GADOLIN)
Lampalizumab
Geographic atrophy
Atezolizumab + abraxane
TNBC
Atezolizumab + Avastin
1L RCC
NM
Es
lin
e
exte
nsio
ns
2016 2017 2018
Actemra
Giant cell arteritis
Alecensa
1L ALK+ NSCLC
2016 outlook
18
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER)
19
Pharmaceuticals Division Daniel O’Day COO Roche Pharmaceuticals
2015 results
Innovation
Outlook
20
2015: Pharma sales
Strong growth driven by all regions
21
2015 2014
CHFm CHFm CHF CER
Pharmaceuticals Division 37,331 36,696 2 5
United States 17,616 15,822 11 6
Europe 8,734 9,422 -7 4
Japan 3,224 3,301 -2 6
International 7,757 8,151 -5 5
Change in %
CER=Constant Exchange Rates
2015: Pharma Division
Core operating profit growth +8%*
22
CHFm % sales
Sales 37,331 100.0
Royalties & other op. inc. 2,119 5.7
Cost of sales -7,900 -21.2
M & D -6,066 -16.2
R & D -8,134 -21.8
G & A -1,295 -3.5
Core operating profit 16,055 43.0
2015 vs. 2014
CER growth
0% in CHF
2015
5%
-11%
7%
4%
4%
-17%
5%
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014
Excl. filgrastim*
+8%
Capacity increase in
manufacturing
Excl. filgrastim*
+10%
-600 -400 -200 0 200 400 600
Pegasys
Valcyte/Cymevene
Tamiflu
Lucentis
Xeloda
Xolair
Kadcyla
Actemra/RoActemra
MabThera/Rituxan
Esbriet
Perjeta
Avastin
Herceptin
US
Europe
Japan
International
2015: Strong performance from oncology and
immunology franchises
23
+10%
+9%
+61%
n.m.
+5%
+51%
+23%
-44%
-45%
+25%
CHFm
Absolute amounts and growth rates at Constant Exchange Rates (CER)
-28%
-15%
-31%
0 2 4 6 8 10
Zelboraf
Xeloda
Tarceva
MabThera/
Rituxan
(Oncology)
Avastin
HER2
Kadcyla
Perjeta
Herceptin +19%
+9%
-7%
-31%
-21%
+4%
2015: Oncology with +8% growth
24
YoY CER growth
CHFbn
CER=Constant Exchange Rates; 2015 Oncology sales: CHF 23.7bn; CER growth +8%
• In-class competition
• EU: Avastin + Tarceva filed in 1L EGFR+ NSCLC
• Loss of exclusivity
• Growth driven mainly by cervical and ovarian
• International: Strong growth in all regions
• Strong uptake of Perjeta and Kadcyla
• Growth of Herceptin due to longer treatment
• Competitive pressure in US and EU
• Cotellic + Zelboraf approved in Q4
• US: Growth in iNHL maintenance
HER2 franchise: Continued strong growth
25
0
500
1,000
1,500
2,000
2,500
Q4 12 Q4 13 Q4 14 Q4 15
Herceptin Perjeta Kadcyla
+10%
YoY CER growth
+19%
+20%
CER=Constant Exchange Rates
CHFm
+18%
HER2 franchise Q4 2015
• Herceptin (+10%): Longer treatment
duration in combo with Perjeta
• Perjeta (+50%): Strong demand in 1L mBC
• Kadcyla (+36%): Growth driven by EU
Outlook 2016
• Perjeta: Further increasing penetration and
neoadjuvant uptake
• Kadcyla: Increasing penetration and new
countries
• Ph III APHINITY data (adj. HER2+) expected
Strong subcutaneous conversion rates for
Herceptin and MabThera
26 SC=subcutaneous; * Herceptin SC has been launched in 48 countries; MabThera SC has been launched in 12 countries
SC share of MabThera NHL
sales in launched countries*
0%
5%
10%
15%
20%
25%
30%
35%
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
Sa
les m
ark
et
sh
are
(%
)
SC share of Herceptin sales in
launched countries*
0%
10%
20%
30%
40%
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
Sa
les m
ark
et
sh
are
(%
)
Check
NHL
sales
Avastin: Growth in various indications and across
all regions
27
0
400
800
1,200
1,600
2,000
Q4 12 Q4 13 Q4 14 Q4 15
CHFm
US Europe International Japan
YoY CER growth
+8%+12%
+9%+8%
CER=Constant Exchange Rates
Avastin Q4 2015
• US (+11%) & EU (+5%): Growth in
ovarian and cervical cancer
• International (+7%): Driven by Asia,
mainly China (lung cancer launch)
Outlook 2016
• Continued uptake in ovarian and cervical
• EU: Avastin + Tarceva approval in EGFR+
NSCLC expected in H2
+8%
Immunology: Continued strong performance
28
0
300
600
900
1,200
1,500
1,800
Q4
12
Q4
13
Q4
14
Q4
15MabThera/Rituxan (RA) Actemra IVActemra SC XolairCellCept PulmozymeEsbriet Other
CHFm
CER=Constant Exchange Rates; MTX=methotrexate; GPA=granulomatosis with polyangiitis; MPA=microscopic polyangiitis
YoY CER growth
+8% +12%
+16%
+26%
Immunology Q4 2015
Xolair (+22%)
• Growth driven by allergic asthma and
chronic idiopathic urticaria
Actemra (+25%)
• SC formulation driving growth
• Increasing 1L monotherapy leadership
focusing on MTX intolerant patients
MabThera/Rituxan (+14%)
• Continues to grow in rheumatoid
arthritis and vasculitis (GPA and MPA)
200
300
400
500
Q3
12
Q4
12
Q1
13
Q2
13
Q3
13
Q4
13
Q1
14
Q2
14
Q3
14
Q4
14
Q1
15
Q2
15
Q3
15
Q4
15
Lucentis: Ongoing competitive pressure
29
Lucentis sales (USDm) Lucentis Q4 2015
• Competitive pressure in wAMD and DME
• Launch in DR ongoing after first-in-class
FDA approval in Q1 2015
• Protocol S results provide evidence of safe
alternative to laser therapy against
proliferative DR
Outlook 2016
• Moderate decline expected
wAMD=wet age-related macular degeneration; DME=diabetic macular edema; DR=diabetic retinopathy (in patients with DME)
27 32
36 44
88
141
157
177
Q1 14 Q2 14 Q3 14 Q4 14 Q1 15 Q2 15 Q3 15 Q4 15
Esbriet: Market leadership in IPF established
30
US
• Strong underlying growth
• Around 100,000 IPF patients in the
US with high unmet need
EU
• Increasing differentiation due to
strengthened label including the
pooled 1 Yr mortality data
Outlook 2016
• Continued growth due to increased
penetration and longer treatment
Esbriet sales (CHFm)
2015 results
Innovation
Outlook
31
2015: Key late-stage news flow
32
Compound Indication Milestone
Regulatory
Avastin Cervical cancer EU approval
Lucentis Diabetic retinopathy US approval
Alecensa 2L ALK+ NSCLC US/EU approval/filing
Cotellic + Zelboraf 1L Melanoma US/EU approval
Phase III readouts*
Gazyva MabThera/Rituxan-refractory iNHL Ph III GADOLIN
Gazyva Front-line aNHL Ph III GOYA (interim)
ocrelizumab Relapsing forms of MS (RMS) Ph III OPERA I/II
ocrelizumab Primary progressive MS (PPMS) Ph III ORATORIO
Perjeta 2L HER2+ mBC Ph III PHEREXA
Kadcyla 2L HER2+ gastric cancer Ph II/III GATSBY
Phase III starts
atezolizumab** 2/3L Bladder cancer Ph III
atezolizumab** 1L TNBC Ph III
atezolizumab** 1L RCC Ph III
atezolizumab** Adjuvant bladder Ph III
etrolizumab Crohn`s disease Ph III
emicizumab (ACE910) Hemophilia A (inhibitors) Ph III
taselisib (PI3K inhib) HR+/PI3Kmut BC Ph III SANDPIPER
Phase II readouts*
atezolizumab 2/3L NSCLC Ph II FIR, POPLAR, BIRCH
atezolizumab Bladder cancer Ph II
ipatasertib (AKT inhib) Gastric/prostate cancers Ph II MARTIN, JAGUAR
* Outcome studies are event driven, timelines may change; ** For atezolizumab (aPDL1) only P3 trials in new indications are listed (1L and sdjuvant NSCLC starts not shown)
2016
Data in-house
Data in-house
Unlocking the full value of cancer immunotherapy
Nine in-house immunotherapy NMEs in the clinic
33
Clinical development Preclinical development
* Partnered or external
Established therapies
Chen and Mellman. Immunity 2013 NME=new molecular entity; CIT=cancer immunotherapy; FP=fusion protein; TCB=T-cell bispecific
T cell Trafficking
Cancer T cell recognition anti-CEA/CD3 TCB
anti-CD20/CD3 TCB
anti-HER2/CD3 TCB
ImmTAC* (Immunocore)
T cell infiltration
anti-VEGF (Avastin)
anti-Ang2/VEGF (vanucizumab)
T cell killing anti-PDL1 (atezolizumab)
anti-CSF-1R (emactuzumab)
IDOi (NewLink)
IDOi* (Incyte)
CPI-444* (Corvus)
anti-TIGIT
IDO1/TDOi* (Curadev)
Antigen presentation T-Vec oncolytic virus* (Amgen)
INFa
anti-CD40
CMB305 vaccine* (Immune Design)
Priming & activation anti-CEA-IL2v FP
anti-FAP-IL2v FP
anti-OX40
anti-CD27* (Celldex)
entinostat* (Syndax)
EGFRi (Tarceva)
ALKi (Alectinib)
BRAFi (Zelboraf)
MEKi (Cotellic)
anti-CD20 (Gazyva)
anti-HER2 (Herceptin;
Kadcyla; Perjeta)
various chemotherapies
lenalidomide*
rociletinib* (Clovis)
Antigen release
In-house immunotherapy NMEs
aCSF-1R
aCEA-IL2v FP
aOX40
aCD40
IDO
aCEA/CD3 TCB
34
Combination trials as of beginning 2015…
Launched/ late-stage portfolio
Immunotherapy portfolio
atezolizumab
polatuzumab
Targeted combinations approved Chemotherapy combinations approved
Roche combinations in trials
Chemotherapy combinations in trials
NMEs late stage
NMEs early stage
venetoclax
chemo
cobimetinib
alectinib
aCSF-1R
aCEA-IL2v FP
aOX40
aCD40
IDO
aCEA/CD3 TCB
aFAP-IL2v FP
aCD20/CD3 TCB
35
…and combination trials as of today
Immunotherapy
portfolio
lenalidomide
azacitidine
polatuzumab
venetoclax
chemo
Targeted combinations approved Chemotherapy combinations approved
Roche combinations in trials
Chemotherapy combinations in trials
Roche NMEs approval expected in 2016
Roche NMEs early stage
Approved non-Roche drugs
Launched/ late-stage portfolio
atezolizumab
Cancer immunotherapy read-outs in 2016
36
Phase III Phase I atezo
2/3L NSCLC
atezo
2/3L Bladder
atezo+Avastin+chemo
1L non sq NSCLC
atezo+chemo
1L non sq NSCLC
atezo+chemo
1L sq NSCLC
atezo
1L non sq NSCLC (Dx+)
atezo
1L sq NSCLC (Dx+)
atezo+chemo
1L TNBC
atezo
Adjuvant MIBC (Dx+)
atezo
Adjuvant NSCLC (Dx+)
atezo+Avastin
1L Renal
atezolizumab trials
NME monotherapy
Immune doublets
Results in 2016
atezo
NSCLC (Dx+)
atezo
2/3L NSCLC
atezo+Avastin
1L Renal
atezo
1/2L Bladder
Phase II
IDO
Solid tumors
atezo+ipilimumab
Solid tumors
atezo+aCD40
Solid tumors
atezo+IFN-alfa
Solid tumors
atezo+aCSF-1R
Solid tumors
atezo+aCEA-IL2v FP
Solid tumors
atezo+aOX40
Solid tumors
atezo+IDO
Solid tumors
atezo+Zelboraf
Melanoma
atezo+Tarceva
NSCLC
atezo+Avastin+/-chemo
Solid tumors
atezo+Gazyva
R/R FL / aNHL
aCD20/CD3 TCB
heme tumors
atezo+Cotellic
Solid tumors
atezo+Zelboraf+Cotellic
Melanoma
atezo+lenalidomide
MM
atezo+chemo
Solid tumors
atezo
Solid tumors
aCSF-1R
Solid tumors
aOX40
Solid tumors
aCEA/CD3 TCB
Solid tumors
aCEA-IL2v FP
Solid tumors
atezo+Alecensa
ALK+ NSCLC
atezo+/-azacitidine
MDS
atezo+Gazyva+chemo
R/R FL/aNHL
atezo+Kadcyla/Herceptin+Perjeta
HER2+ eBC/mBC
atezo+Gazyva+lenalidomide
R/R FL/aNHL
Additional 2016 results (according
to Eka`s publication list):
• Ph1: Atezo+Avastin+FOLFOX in
1L CRC
• Ph3 interim: Atezo+abraxane in
TNBC
• Ph1: aCD20/CD3 TCB
• Ph1: Atezo+lena SAFETY
• Ph1: Atezo+azacitidine SAFETY
atezo+Gazyva+polatuzumab
R/R FL/aNHL
Should we
indicate
what could
be at
ASCO?
aFAP-IL2v FP
Solid tumors
Status as of Jan 28, 2016; Outcome studies are event-driven: timelines may change.
atezo+aCEA/CD3 TCB
Solid tumors
37
Alecensa in 2L ALK+ lung cancer
First ALK inhibitor with proven activity in the brain
Phase II US and Global Studies
0
10
20
30
40
50
60
70
80
All (n=67) Measurable
CNS disease
(n=16)
All (n=122) Measurable
CNS disease
(n=34)
ORR
CR
US Study Global Study
52%
75%
51%
59%
25% 21%
All
(n=69)
Ove
rall a
nd C
NS R
esp
onse
Rate
s
• Accelerated approval in US; Filed in
the EU in Q3
• High systemic and CNS disease
control in crizotinib-failed lung cancer
• Phase III results (ALEX) in 1L ALK+
NSCLC expected in 2017
Alecensa (alectinib); ORR=overall response rate; CR=complete responses; CNS=central nervous system; PFS=progression free survival;
DOR=duration of response; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015
Mention
sales in
Japan ?
• Median PFS: 8.1m (US) , 8.9m (global)
• Median DOR: 13.5m (US),14.1m (global)
38
Cotellic + Zelboraf in 1L BRAFmut melanoma
Triple combination with atezolizumab started
Cotellic (cobimetinib); OS=overall survival; PFS=progression free survival; ORR=overall response rate; CR=complete responses;
Atkinson V. et al, SMR 2015; Shaw A. et al, WCLC 2015; Barlesi F. et al, ESMO/ECC 2015
Phase III coBRIM Study
• Approved in the US/EU
• Ph I data (at SMR) show that atezolizumab
can be combined with Zelboraf
• Ph I triplet combination of atezolizumab +
Zelboraf + Cotellic on-going
Zelboraf +
Cotellic
(n = 247)
Zelboraf +
Placebo
(n = 248)
Median OS 22.3 17.4
Median PFS 12.3 7.2
% ORR 69.6 50.0
% CR 15.8 10.5
Ocrelizumab in multiple sclerosis
First drug active in both RMS and PPMS
39 RMS=relapsing forms of multiple sclerosis (MS) which includes patients with RRMS and SPMS with superimposed relapses; RRMS=relapsing-remitting MS; SPMS=secondary progressive MS; PPMS=primary progressive MS
Phase III OPERA I/II Studies (RMS) Phase III ORATORIO Study (PPMS)
• First and only investigational medicine to suppress disease progression in both RMS and PPMS
• Results confirm B cells play a central role in MS
• US/EU filing for RMS and PPMS on track for H1 2016
Emicizumab (ACE910) in hemophilia A
First-patient-in achieved in inhibitor study
40 QW=weekly dosing; Q2W= dosing every 2 weeks; Q4W=monthly dosing; PK=pharmacokinetic study; OLE=open label extension
• First-patient-in in the inhibitor phase III study achieved
• Inhibitor non-interventional study has recruited >90 patients and will be expanded to non-inhibitors
• Non-inhibitor and pediatrics studies expected to start in 2016
• New data at ASH 2015: Patient underwent surgery without need for any Factor VIII replacement therapy
2015 2016 2017 2018
Pediatrics Inhibitor
Inhibitor Non-interventional
Inhibitor (≥12 yrs)
Weight based QW dosing
(Q4W dosing study planned)
Non-inhibitor (≥12 yrs)
QW and Q2W dosing
Japanese studies
Chugai OLE
Phase II Phase III Phase I Patient transfer
Real World Data
Strengthening Pharma through collaborations
Data analysis driving innovation and efficiencies
41
Access meaningful data Create insights Create insights Realise value
Advanced analytics
of integrated data
Diagnostic Data
Clinical Trial Data
Smarter, more efficient
R&D
Improved access &
personalised patient care
2015 results
Innovation
Outlook
42
2016 onwards: Significant launch activities
43 Outcome studies are event-driven: timelines may change. Standard approval timelines of 1 year assumed.
FDA Breakthrough
Therapy Designation
Oncology/
hematology Neuroscience Ophthalmology Immunology
Cotellic + Zelboraf
BRAFmut melanoma
Venetoclax
R/R CLL including 17p del
Ocrelizumab
RMS/ PPMS
Lebrikizumab
Severe Asthma
Emicizumab (ACE910)
Hemophilia A
Atezolizumab
2L+ lung and bladder cancer
Alecensa
2L ALK+ lung cancer
Perjeta + Herceptin
eBC HER2+ (APHINITY)
Atezolizumab+Avastin+chemo
1L NSCLC
Gazyva
1L aNHL (GOYA)
Gazyva
1L iNHL (GALLIUM)
Gazyva
Refractory iNHL (GADOLIN)
Lampalizumab
Geographic atrophy
Atezolizumab + abraxane
TNBC
Atezolizumab + Avastin
1L RCC
NM
Es
lin
e
exte
nsio
ns
2016 2017 2018
Actemra
Giant cell arteritis
Alecensa
1L ALK+ NSCLC
2016: Key late-stage news flow
44
Compound Indication Milestone
Regulatory
Gazyva MabThera/Rituxan-refractory iNHL US/EU approval
venetoclax R/R CLL US approval
ocrelizumab RMS/PPMS US/EU filing
atezolizumab Bladder cancer US approval
atezolizumab 2/3L NSCLC US approval
Alecensa 2L ALK+ NSCLC EU approval
Phase III readouts*
lebrikizumab Severe asthma Ph III LAVOLTA I/II
atezolizumab 2/3L NSCLC Ph III OAK
Gazyva Front-line aNHL Ph III GOYA
Perjeta + Herceptin Adjuvant HER2+ BC Ph III APHINITY
Actemra Giant cell arthritis Ph III GiACTA
Alecensa 1L ALK+ NSCLC Ph III ALEX
Phase II readouts*
lebrikizumab Atopic dermatitis Ph II TREBLE, ARBAN
atezolizumab Bladder cancer Ph II IMvigor 210 (1L cohort)
atezolizumab + Avastin 1L Renal cancer Ph II IMmotion 150
venetoclax R/R FL (iNHL) Ph II CAVALLI
venetoclax 1L aNHL Ph II CONTRALTO
* Outcome studies are event driven, timelines may change
Compound Indication Milestone
Regulatory
Gazyva MabThera/Rituxan-refractory iNHL US/EU approval US 28 Feb; EU
May
venetoclax R/R CLL US approval March
ocrelizumab RMS/PPMS US/EU filing Q2
atezolizumab Bladder US approval Sep launch
atezolizumab 2/3L NSCLC US approval Oct launch
Alecensa 2L ALK+ NSCLC EU approval Q4
Avastin Relapsed Platinum-sensitive OC US/EU filing
Phase III
readouts*
lebrikizumab Moderate to severe asthma Ph III LAVOLTA I/II Feb ATS
atezolizumab 2/3L NSCLC Ph III OAK Q3 WCLC
Gazyva Front-line aNHL Ph III GOYA (interim) Mid July ASH
Perjeta Adjuvant HER2+ BC Ph III APHINITY Q1 17 SABCS
Perjeta 2L HER2+ mBC Ph III PHEREXA ASCO
Kadcyla Neoadjuvant HER2+ BC Ph III KRISTINE (5% sucess) Feb ASCO
Gazyva Front-line iNHL Ph III GALLIUM (interim) Late May ASH
Perjeta 1L mGC Ph III JACOB (interim OS) June/July
Actemra Giant cell arthritis Ph III GIACTA Q3 ACR
Alecensa 1L ALK+ NSCLC Ph III ALEX (PFS) Sep
venetoclax R/R CLL Ph III MURANO Q4
Zelboraf Adjuvant melanoma Ph III BRIM8 Q4
Phase II
readouts*
atezolizumab + Avastin 1L RCC Ph II IMmotion ASCO
lebrikizumab Atopic dermatitis Ph II
venetoclax R/R FL (iNHL) Ph I/II CAVALLI ASCO
ipatasertib Gastric/prostate cancers Ph II MARTIN, JAGUAR ESMO?/ASCO
polatuzumab + R/G-CHP 1L aNHL Ph I/II (Ph2 expansion?) ASCO/ASH
polatuzumab + R/G-CHP NHL Ph II ROMULUS ASCO/ASH
vanucizumab CRC Ph II McCAVE
taselisib Neoadjuvant (1L) TNBC Ph II LORELEI SABCS
atezolizumab Bladder Ph II Imvigor 210 (1L cohort) ASCO
SERD ER+/HER2- mBC Ph II SABCS
lifastuzumab vediotin Platinum-sensitive OC Ph II
venetoclax 1L aNHL Ph II CONTRALTO ASH
45
Diagnostics Division Roland Diggelmann COO Roche Diagnostics
2015: Diagnostics sales
Strong sales performance
46
2015 2014
CHFm CHFm CHF CER
Diagnostics Division 10,814 10,766 0 6
Professional Diagnostics 6,175 6,045 2 8
Diabetes Care 2,128 2,392 -11 -3
Molecular Diagnostics 1,719 1,613 7 10
Tissue Diagnostics 792 716 11 12
Change in %
CER=Constant Exchange Rates; Underlying growth of Molecular Diagnostics excluding Sequencing business: +7%
0%
1%
2%
3%
4%
5%
6%
7%
8%
Market
Roche
Roche outgrowing the market in a challenging
environment
47 Sources: 3rd party IVD consultancy, Analyst reports, Roche Analysis; *Q4 2015 market growth is an estimate
Quarterly growth (%)
2015 2014
FY 2015: 6%
Q3 Q2 Q1 Q4 Q3 Q2 Q1 Q4
• Worldwide IVD market leader
• Strong commercial presence
• Broadest test menu
*
North America
+3%
26% of divisional sales
Latin America
+11%
7% of divisional sales
Japan
0%
4% of divisional sales EMEA1
+4%
42% of divisional sales
2015: Diagnostics regional sales
Growth driven by APAC and EMEA
Asia Pacific
+15%
21% of divisional sales
48
14% growth in E7 countries2
1Europe, Middle East and Africa; 2Brazil, China, India, Mexico, Russia, South Korea, Turkey All growth rates at Constant Exchange Rates
2015: Diagnostics highlights
Growth driven by Professional Diagnostics
+12%
-3%
+8%
+10%
CHFbn
1
1 Underlying growth of Molecular Diagnostics excluding Sequencing Solutions: +7%
CER=Constant Exchange Rates; EMEA=Europe, Middle East and Africa
• Virology (+14%) incl. HPV (+27%)
• Decline in blood glucose monitoring (-4%), insulin delivering systems (+8%)
• Advanced staining portfolio (+11%)
• Growth driven by immunodiagnostics (+13%)
YoY CER growth
49
0 2 4 6 8
Tissue
Dia
Molecular
Dia
Diabetes
Care
Professional
Dia
EMEA
North America
RoW
2015: Diagnostics Division
Profitability impacted by investments in sequencing*
50
CHFm % sales
Sales 10,814 100.0
Royalties & other op. inc. 139 1.3
Cost of sales -4,806 -44.5
M & D -2,544 -23.5
R & D -1,198 -11.1
G & A -458 -4.2
Core operating profit 1,947 18.0
2015 2015 vs. 2014
CER growth
-7% in CHF
6%
5%
7%
9%
18%
-9%
-2%
CER=Constant Exchange Rates; * Sequencing investments refer to the acquisitions of Genia, Ariosa, Bina and Signature Diagnostics
Immunodiagnostics: 15 years of consecutive
double digit growth
51
0.0
0.5
1.0
1.5
2.0
2.5
3.0
3.5
2000 2015
+13%
CHFbn
All growth at CER=Constant Exchange Rates
Continuous extension
• 100+ assays
• Largest installed instrument base
• Mfc capacity expansion in 2015
Outlook
• Launch of cobas e801 instrument: Double throughput with same footprint
• New reagent plant in China
Elecsys Troponin T high sensitive (TnT-hs)
Safe and effective AMI* rule-in and rule-out in 1 hour**
Rule-in
Rule-out
Observation
Conventional assays
High sensitive assays
TnT-hs One-hour algorithm
3 hours
1 hour
Enables faster treatment decisions and reduced ER waiting times
?
Reduces diagnosis time to 1h in 76-78% of acute chest pain patients
TRAPID
-AMI
* AMI: acute myocardial infarction; ** 1 hour refers to time for analysis between two samples
References: 1. Mueller, C. et al (2015) : Ann Emerg Med. 10.1016/j.annemergmed.2015.11.013
http://www.annemergmed.com/article/S0196-0644(15)01501-2/fulltext.. 2.Reichlin et al (2012). Arch Intern Med 172:1211-1218.
52
6 hours
cobas 6800 cobas 8800
Molecular Diagnostics: cobas 6800/8800
US launch of instruments and viral load tests*
53
• Fully automated PCR systems
• Highest throughput
(3x above closest competitor)
• Highest walk-away time to
increase lab efficiency
Blood Screening Virology Menu Expansion
• MPX (HIV, HCV, HBV)
• West Nile Virus • DPX (B19 & HAV)
• Hepatitis E
• HIV-1
• Hepatitis B • Hepatitis C
• CMV
• HPV
• CT/NG • HIV 1/2 Qualitative
• MTB/MAI & RIF/INH
* US approved tests for cobas 6800/8800: HBV, HCV and HIV-1
Tissue Diagnostics: Launch of VENTANA HE 600
Potential to change standard of care in H&E* staining
54
• Latest platform with individual slide staining
technology, avoids sample cross contamination
• Platform features:
– Highest result quality and reproducibility
– Highest test capacity and most efficient
workflow
– Easy and safe to operate
* hematoxylin and eosin tissue staining
Accu-Chek Insight CGM
Diabetes Care: Challenging US market
Launch of innovative products in 2016
Challenges in 2015:
• US: Spillover effect of Medicare prices to private sector
55
Opportunities in 2016:
• Product launches
– Accu-Chek Guide: New blood glucose monitoring
device with universal test strip for improved accuracy
– Accu-Chek Insight CGM*: New sensor technology
• Growth prospect
– Insulin Delivery Systems: Sustaining current growth
momentum
Accu-Chek Guide
* CGM: Continuous glucose monitoring
1 Business Areas. RPD: Roche Professional Diagnostics; RDC: Roche Diabetes Care; RMD: Roche Molecular Diagnostics;
RTD: Roche Tissue Diagnostics; * Submitted to FDA
Key launches 2015
56
Area Product Market BA1
Instruments /
Devices
Laboratory
cobas c 513 – dedicated HbA1C analyzer
cobas t 411– core lab coagulation analyzer
cobas 8100 V2 – Integrated pre- and post-analytical solution
cobas 6800/8800 – Medium to High volume automated real-time PCR
VENTANA HE 600 – automated H&E staining platform
EU
EU
WW
US
WW
RPD
RPD
RPD
RMD
RTD
Diabetes
Care
Accu-Chek Active no-code– next-gen. bG meter, no coding of test strips
Accu-Chek Connect – bG meter with connectivity to smartphones, mobile
applications and cloud
WW
US
RDC
RDC
Point of Care CoaguChek Pro II - professional system for PT and aPTT testing EU RPD
Tests /
Assays
Blood
Screening cobas 6800/8800 MPX – Multiplex Bloodscreening test US RMD
Infectious
Diseases
cobas Liat Influenza A/B + RSV – POC detection
HTLV– human T-lymphotropic virus diagnostics test
US
EU
RMD
RPD
Virology
cobas 6800/8800 HBV – Quantitative HBV viral load test
cobas 4800 HIV-1 - Quantitative HIV viral load test
cobas 4800 HCV – Quantitative HCV viral load test
cobas 4800 HBV – Quantitative HBV viral load test
EU
EU
EU
EU
RMD
RMD
RMD
RMD
Genomics &
Oncology cobas EGFR Test v2 - detection of EGFR in plasma EU RMD
Cardiac cobas h 232 Troponin T – Point of Care test version of Elecsys cTNT-hs EU RPD
*
*
Key launches 2016
57
Area Product Market
Instruments /
Devices
Central
Laboratory
cobas 8000 <e 801> – high throughput immunochemistry analyzer
cobas c 513 – high throughput dedicated HbA1c analyzer
EU
US
Point of Care CoaguChek INRange (Zenith) – modified analyzer for intuitive self testing with full blue
tooth connectivity EU
Sequencing Roche SMRT Sequencer – single molecule sequencer for clinical research (in collaboration
with Pacific Biosciences) WW
Diabetes
Care
Accu-Chek Guide – next-generation blood glucose monitoring system
Accu-Chek Insight CGM – new high-performance continuous glucose monitoring system
EU
EU
Tests /
Assays
Virology cobas 6800/8800 HIV Qual – early Infant Diagnosis and Confirmatory HIV Test EU
HPV /
Microbiology cobas 6800/8800 CT/NG – fully automated solution for screening and diagnosis of Chlamydia
trachomatis and Neisseria gonorrhoeae in symptomatic & asymptomatic patients EU
Point of Care cobas Liat Influenza A/B plus RSV (CLIA) – automated multiplex real time RT-PCR
assay for qualitative detection and discrimination of Influenza A virus, Influenza B virus and respiratory syncytial virus (RSV)
US
Sequencing ctDNA oncology panels – liquid biopsy for circulating tumor DNA for cancer therapy
selection US
Companion
Diagnostics
PD-L1 (SP142) for Bladder Cancer* – companion diagnostic for atezolizumab PD-L1 (SP142) for NSCLC* – companion diagnostic for atezolizumab
US
US
* achieve commercial readiness, dependent on Pharma label and approval
58
Finance Alan Hippe Chief Financial Officer
2015: Highlights
59
Business
• Strong sales growth of +5%1 and Core EPS growth +7%1 excluding filgrastim2
• Core operating profit up +5%1, excluding filgrastim2 +7%1
• Dividend in Swiss franc and payout ratio further increased
Debt restructuring
• Attractive financing conditions in capital markets used for major debt restructuring
– Total major restructuring of USD 0.9bn and EUR 0.4bn in 2015
• Lower interest expenses of CHF 61m despite average gross debt of CHF 24bn in 2015 vs.
CHF 21bn in 2014
1 At Constant Exchange Rates (CER); 2 Excluding sale of filgrastim rights in 2014
Cash flow
• Cash generation remains strong (Op. FCF of CHF 14.9bn) despite expanding manufacturing
network and investments in intangible assets
• Accounts receivable in Southern Europe further decreased
2015 2014 Excl.
CHFm CHFm CHF CER filgrastim*
Sales 48,145 47,462 1 5
Core operating profit 17,542 17,636 -1 5 7
as % of sales 36.4 37.2
Core net income 11,837 12,533 -6 1 4
as % of sales 24.6 26.4
Core EPS (CHF) 13.49 14.29 -6 4 7
IFRS net income 9,056 9,535 -5 4
Operating free cash flow 14,872 15,778 -6 -7
as % of sales 30.9 33.2
Free cash flow 3,352 5,322 -37 -41
as % of sales 7.0 11.2
Change in %
2015: Group performance
Core EPS growth +4%, +7% excluding filgrastim*
60 CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014
2015: Group operating performance
Core OP growth +5%, +7% excluding filgrastim
61
CHFm % sales
Sales 48,145 100.0
Royalties & other op. inc. 2,258 4.7
Cost of sales -12,706 -26.4
M & D -8,610 -17.9
R & D -9,332 -19.4
G & A -2,213 -4.6
Core operating profit 17,542 36.4
2015 2015 vs. 2014
CER growth
-1% in CHF
5%
-10%
7%
5%
5%
-12%
5%
CER=Constant Exchange Rates; * Excluding sale of filgrastim rights in 2014
Excl. filgrastim*
+7%
17,904
16,108
2,177
17,63616,001
2,096
17,54216,055
1,947
Roche Group Pharma Division Diagnostics Division
2013 2014 2015
38.3% 37.2% 36.4%
44.4% 43.6% 43.0%
20.8% 19.5%18.0%
2015: Strong Core operating profit and margin
62
CHFm
% of sales
-0.2%p1
(-0.8%p)
-1.4%p1
(-1.5%p)
+0.2%p1
(-0.6%p)
-2%1
(-7%)
+5%1
(0%)
+5%1
(-1%)
1 At CER=Constant Exchange Rates; 2 Excluding sale of filgrastim rights in 2014
+0.7 %p2 +1.4 %p2
-1,116
-1,416
+136 -281
-212
+61
-4
Interest expense
2014 2015 Net losses on debt
redemption
All other, net
Net income from equity securities
2015 with 27% CHF / 26% CER
higher net financial expense
2015: Core net financial result
Net financial expense up vs. prior year due to higher FX losses and lower income from equities
63 CER=Constant Exchange Rates
CHFm
FX G/L
24.1 26.6
+2.5
2014 Profit mix and other 2015
2015: Group Core tax rate
Relative higher Core profits in US
64
Figures in %
Relative higher
Core profits in
US and other
19%
Net debt/
total assets:
Assets Equity & liabilities
44.4 47.6
21.6 23.3
19.419.0
30.8 28.7
11.7 9.2
23.1 23.8
31/12/14 31/12/15 31/12/14 31/12/15
75.8 75.8+4%
-15%
+4%
+10%
Current
liabilities
Non-current
liabilities
Equity
(Net assets)
15% 12%
26%
59%
25%
29% 31%
75.5 75.5
% change in CER
vs 31/12/14
Current
liabilities
Non-current
liabilities
Equity
(Net assets)
63%
30%
41%
31%
38%
+6%
% change in CER
vs 31/12/14
+4%
-4%
+14%
Cash and
marketable
securities
Other
current
assets
Non-current
assets
CHFbn
Balance sheet 31 December 2015
65 CER=Constant Exchange Rates
16,38114,976
1,962
15,77814,821
1,417
14,872 14,482
963
Roche Group Pharma Division Diagnostics Division
2013 2014 2015
35.0% 33.2%30.9%
41.3% 40.4% 38.8%
18.7%13.2%
8.9%
2015: Operating free cash flow and margin
66
CHFm
-3.8%p1 (-2.3%p)
-7%1
(-6%)
1 At CER=Constant Exchange Rates
• Capex driven by expanding
manufacturing network
• Investments in intangible assets
CCC-
BB
BBB-
BBB
CHFm
2,462
1,036
980
209
236
1,836
604
819
163
251
1,645
613
733
114
185
1,171
480
433
97
161
991
322
390
103
176
0 500 1,000 1,500 2,000 2,500
Southern
European
Countries
Spain
Italy
Portugal
Greece
Dec 2015
Dec 2014
Dec 2013
Dec 2012
Dec 2011
-60%
2015: Accounts receivable in Southern Europe
further decreased
67 Sovereign country ratings from Standard & Poor’s, as of 6 Jan 2016
-14.0 +14.9 -14.1
-11.5
-3.5 Dividends -7.0
Taxes -3.7
Treasury -0.8
2015: Group net debt development
Net debt stable vs. 2014
68
0
Net debt
31 Dec 2014
Operating Free
Cash Flow
Business combinations, Currency translation
& other
Net debt
31 Dec 2015
Non-op. FCF
Free Cash Flow CHF 3.4bn
vs. 5.3bn in 2014
CHFbn
Business combinations -2.1
Currency translation, other -1.4
CER
sales
growth
2015
vs.
2014
Exchange rate impact on sales growth
Negative impact from EUR, LATAM and Europe more than offsetting positive impact of USD
CER = Constant Exchange Rates (avg full year 2014)
+5.3%
+1.4%
+2.3p -0.1p -0.3p -0.7p
-1.0p
-1.4p
-2.7p
CER USD As-Pac Other JPY Other
Europe
LATAM EUR CHF
CHF
sales
growth
2015
vs.
2014
69
Currency impact in 2015/2016
Q1 HY Sep
YTD
FY
Sales -2 -3 -4 -4
Core
operating
profit
-4 -6
Core EPS -7 -10
In 2015 impact1 is (%p): CHF / USD
CHF / EUR
+1%
+1%
+2% +2%
0.95 0.93 0.96 0.970.950.93 0.93 1.01 0.990.970.970.98
0.950.95
0.95
0.96
0.91
0.890.900.89
J F M A M J J A S O N D
1.10 1.06 1.06 1.04 1.04 1.05 1.05 1.08 1.09 1.09 1.08 1.08
1.22 1.22 1.211.22
1.071.06
1.08 1.06
J F M A M J J A S O N D
Average
YTD
2014
7% 6%
6% 5%
-12% -13% -13% -12%
Average
YTD 2015
Monthly avg fx rates 2015 Fx rates at 31 Dec 2015
70
In 2016 currency impact1 expected is
(based on 31 Dec 2015 FX rates):
• No FX impact on sales
• -2%p on Core OP and up to -5%p on
Core EPS
1 On Group growth rates
2016 outlook
71
Group sales growth1 Low to mid-single digit
Core EPS growth1 Ahead of sales growth
Dividend outlook Further increase dividend in Swiss francs
1 At Constant Exchange Rates (CER)
Changes to the development pipeline
Q4 2015 update
73
New to Phase I New to Phase II New to Phase III New to Registration 7 NMEs transitioned from Ph0
RG4929 NME – glaucoma
RG7834 NME – HBV
RG7461 FAP IL2v FP – solid tumors
RG7916 SMN2 (2) splicer – SMA
RG7845 BTK ihn - autoimmune diseases
RG7861 NME – infectious diseases
RG7992 NME – metabolic diseases
1 NME following Adheron acquisition
RG6125 Cadherin-11 MAb - RA
4 AIs
RG7159 obinutuzumab – hypersensitized
renal transplant
RG7159 Gazyva multiple combos - heme
indications
RG3616 Erivedge + Esbriet – IPF
RG7446 atezolizumab combo Kadcyla/
Herceptin+Perjeta – HER2+ breast cancer
1 AI
RG7159 obinutuzumab – lupus
nephritis
1 opt-in deal signed
PRO VAP-1 inh – inflammatory
diseases
1 NME transitioned from Ph1
RG7388 idasanutlin – AML
1 NME transitioned from Ph2
RG6013 emicizumab (FIXa/FX
bispecific MAb) – hemophilia A
1 AI transitioned from Ph2
RG1569 Actemra – systemic
sclerosis
2 NMEs transitioned from Ph2
RG7446 atezolizumab – bladder
cancer 2L
RG7601 venetoclax – CLL rel/ref
Removed from Phase I Removed from Phase II Removed from Phase III Removed from Registration
2 NMEs
RG7450 anti-Steap 1 ADC – prostate ca.
RG7689 NME – infectious diseases
1 NME
RG7599 lifastuzumab vedotin – Pt-
resistant ovarian cancer
1 AI
RG3502 Kadcyla – HER2+
gastric cancer 2L
1 NME following approval in
EU/US
RG7421 Cotellic+Zelboraf –
metastatic melanoma
Status as of January 28, 2016
Roche Group development pipeline
74
Phase I (40 NMEs + 17 AIs)
Raf & MEK dual inh solid tumors
ChK1 inh solid tum & lymphoma
lumretuzumab mBC
atezo+Zelboraf+/-Cotellic melanoma
atezo+Avastin+chemo solid tumors
atezo+Tarceva /Alecensa NSCLC
atezolizumab+Cotellic solid tumors
venetoclax+Gazyva CLL
atezolizumab solid tumors
ERK inh + Cotellic solid tumors
LSD1 inh AML
anti-Ly6E ADC solid tumors
MDM2 (4) IV prodrug AML
ADC ovarian ca
atezolizumab+ipi/IFN solid tumors
OX40 MAb solid tumors
ranibizumab PDS wAMD
Nav1.7 inh pain
VEGF-ANG2 biMAb wAMD
a-synuclein MAb Parkinson's Disease
SMN2 splicer spinal muscular atrophy
RG3645
RG7893
RG7716
RG7935
RG7800
HIF1 alpha LNA solid tumors
RG7304
RG7741
RG7116
RG7446
RG7446
RG7446
RG7446
RG7601
RG7446
RG7842
RG6016
RG7841
RG7775
RG7882
RG7446
RG7888
RG6061
CEA CD3 TCB+atezolizumab s. tumors RG7802
CD40 MAb+atezolizumab solid tumors RG7876
atezolizumab+Gazyva lymphoma RG7446
IL-22Fc inflammatory diseases RG7880
Cat-S antag autoimmune diseases RG7625
DBO β-lactamase inh bact. infections RG6080
emactuzumab + atezolizumab s. tumors RG7155
SERD (2) ER+(HER2-neg) mBC RG6047
IDO inh solid tumors RG6078
duligotuzumab + Cotellic solid tumors RG7597
venetoclax heme indications RG7601
therapeutic vaccine HBV RG7944
CEA IL2v FP+atezolizumab solid tumors RG7813
OX40 MAb + atezolizumab solid tumors CLL RG7888
- fibrosis RG6069
atezo+lenalidomide multiple myeloma RG7446
IDO inh + atezolizumab solid tumors RG6078
PTH1 recep. ago hypoparathyroidism CHU
crenezumab Alzheimer’s RG7412
basimglurant TRD
polatuzumab vedotin heme tumors RG7596
V1 receptor antag autism RG7314
ipatasertib solid tumors RG7440
Flu A MAb influenza A RG7745
nemolizumab (IL-31R) atopic dermatitis CHU
atezolizumab NSCLC 2/3L RG7446
basmisanil Down syndrome RG1662
emactuzumab PVNS/solid tumors RG7155
vanucizumab mCRC RG7221
Cotellic+paclitaxel TNBC RG7421
SERD ER+(HER2-neg) mBC RG6046
URAT1 inh gout CHU
Kadcyla HER2+ NSCLC RG3502
lebrikizumab +/- Esbriet IPF RG3637
olesoxime spinal muscular atrophy RG6083
TLR7 agonist HBV RG7795
lebrikizumab atopic dermatitis RG3637
Phase II (18 NMEs + 13 Als)
CD20/CD3 biMAb heme tumors RG7828
ASO Huntington’s Disease IONIS
Flu B MAb influenza B RG6024
FAP-DR5 biMAb solid tumors RG7386
lebrikizumab COPD RG3637
- glaucoma
nemolizumab (IL-31R) pruritus dialysis pts CHU
danoprevir HCV RG7227
obinutuzumab renal transplant RG7159
Cadherin-11 MAb RA RG6125
RG4929
- HBV
FAP IL2v FP solid tumors
SMN2 splicer(2) spinal muscular atrophy
BTK inh autoimmune diseases
- infectious diseases
RG7834
RG7461
RG7916
RG7845
RG7861
- metabolic diseases RG7992
RG7861
PT - hyperphosphatemia CHU
RG-No Roche/Genentech managed
CHU Chugai managed
IONIS IONIS managed
PRO Proximagen managed
codrituzumab liver cancer RG7686
taselisib ER+(HER2-neg) BC neoadj RG7604
taselisib NSCLC sq 2L RG7604
venetoclax DLBCL RG7601
venetoclax+Rituxan FL rel/ref RG7601
obinutuzumab lupus nephritis RG7159
RG7090
VAP-1 inh inflammatory diseases PRO
Gazyva multiple combos heme indications RG7159
atezolizumab + K/HP HER2+ BC RG7446
RG7986
Nav1.7 inh (2) pain RG6029
Erivedge+Esbriet IPF RG3616*
ADC r/r NHL RG7986
Immunology
New Molecular Entity (NME)
Oncology
Other
Ophthalmology Neuroscience
Infectious Diseases
CardioMetabolism
Additional Indication (AI)
Status as of January 28, 2016
Roche Group development pipeline
75
Phase III
(9 NMEs + 30 Als)
1 Global filing
2 EU only
3 Phase 3 ongoing
4 Approved in the US and Japan
lampalizumab geographic atrophy RG7417
Avastin glioblastoma 1L RG435
ocrelizumab RMS RG1594
Gazyva DLBCL1L RG7159
ocrelizumab PPMS RG1594
Actemra large-vessel vasculitis CHU
lebrikizumab severe asthma RG3637
Zelboraf melanoma adj RG7204
Perjeta+Herceptin HER2+gastric ca 1L RG1273
Actemra giant cell arteritis RG1569
etrolizumab ulcerative colitis RG7413
Perjeta+Herceptin HER2+ mBC 2L RG1273
Alecensa (alectinib) ALK+ NSCLC 1L RG7853
Gazyva iNHL rituximab-refractory RG7159
Gazyva follicular lymphoma 1L RG7159
venetoclax+Rituxan CLL rel/ref RG7601
gantenerumab Alzheimer’s RG1450
atezolizumab NSCLC 2L RG7446
Kadcyla + Perjeta HER2+ BC adj RG3502
Kadcyla + Perjeta HER2+ BC neoadj RG3502 IL-6R MAb neuromyelitis optica CHU
Perjeta+Herceptin HER2+ BC adj RG1273
Kadcyla HER2+ BC adj RG3502
venetoclax+Gazyva CLL 1L RG7601
Avastin rel. ovarian ca. Pt-sensitive RG4351
atezolizumab bladder cancer 2L RG74463
atezolizumab+Avastin RCC RG7446
MabThera SC CLL RG105
Avastin+Tarceva EGFR mut+ NSCLC RG4352
atezolizumab+chemo NSCLC non-sq. 1L 1L RG7446
NSC atezo+chemo+Avastin NSCLC non-sq. 1L RG7446
atezolizumab+chemo NSCLC sq. 1L RG7446
atezolizumab Dx+ NSCLC sq. 1L RG7446
atezolizumab Dx+ NSCLC non-sq. 1L RG7446
taselisib ER+(HER2-neg) mBC RG7604
etrolizumab Crohn’s disease RG7413
MabThera pemphigus vulgaris RG105
atezolizumab+abraxane TNBC RG7446
atezolizumab Dx+ NSCLC adj RG7446
atezolizumab muscle inv. bladder ca adj RG7446
Registration
(3 NMEs + 3 Als)
Alecensa (alectinib) ALK+ NSCLC 2L RG78534
idasanutlin AML RG7388
emicizumab (FIXa/FX biMAb)hemophilia A RG6013
venetoclax CLL rel/ref RG7601
Actemra systemic sclerosis RG1569
Immunology
New Molecular Entity (NME)
RG-No Roche/Genentech managed
CHU Chugai managed
ISIS ISIS managed
PRO Proxymagen managed
RG105 MabThera is branded as Rituxan in US and Japan
RG1569 Actemra is branded as RoActemra in EU
RG7159 Gazyva is branded as Gazyvaro in EU
Oncology
Other
Ophthalmology
Neuroscience
Infectious Diseases
CardioMetabolism
Additional Indication (AI)
Immunology
Status as of January 28, 2016
NME submissions and their additional
indications
Projects currently in phase II and III
76 Unless stated otherwise, submissions are planned to occur in US and EU
✓Indicates a submission which has occurred with regulatory action pending * EU submission pending
ocrelizumab (RG1594) RMS
danoprevir (RG7227) HCV
crenezumab (RG7412) Alzheimer‘s
gantenerumab (RG1450) Alzheimer‘s
V1 receptor antag (RG7314) autism
codrituzumab MAb (RG7686) liver cancer
lampalizumab (RG7417) geographic atrophy
lebrikizumab (RG3637) severe asthma
etrolizumab (RG7413) ulcerative colitis
2015 2018 and beyond
atezolizumab(RG7446) NSCLC 2/3L
ipatasertib (RG7440) solid tumors
polatuzumab vedotin (RG7596)
heme tumors
lebrikizumab+/-Esbriet (RG3637) IPF
2016
atezolizumab(RG7446) combo Avastin RCC
Flu A MAb (RG7745) influenza
taselisib (RG7604) HER2 neg ER+ mBC
basmisanil GABRA5 NAM
Down syndrome
atezolizumab US* ✓
bladder cancer 2L
emactuzumab (RG7155)
PVNS and solid tumors
venetoclax (RG7601)
DLBCL
vanucizumab (RG7221)
colorectal cancer
ocrelizumab (RG1594) PPMS
emicizumab FIXa /FX biMAb (RG6013) hemophilia A
Cotellic+paclitaxel TNBC
venetoclax (RG7601) + Gazyva CLL 1L
venetoclax (RG7601) + Rituxan FL rel/ref CLL
venetoclax (RG7601) ✓ CLL rel/ref
SERD (RG6046) ER+(HER2-neg) mBC
2017
Alecensa (alectinib) ✓ Alk+ NSCLC 2L
olesoxime (RG6083) SMA
atezolizumab(RG7446)+ chemo NSCLC non-sq 1L
etrolizumab (RG7413) Crohn’s disease
atezolizumab(RG7446) NSCLC sq 1L (Dx+)
atezolizumab(RG7446) NSCLC non-sq 1L (Dx+)
atezolizumab(RG7446)+ chemo NSCLC sq 1L
atezolizumab(RG7446)+chemo + Avastin NSCLC non-sq 1L
taselisib ( RG7604) ER+(HER2-neg) BC neoadj
New Molecular Entity Oncology
Immunology
Infectious Diseases
CardioMetabolism
Neuroscience
Ophthalmology
Other
venetoclax+Rituxan (RG7601) CLL rel/refractory
Status as of January 28, 2016
lebrikizumab (RG3637) atopic dermatitis
TLR7 ago (RG7795) HBV
atezolizumab (RG7446) NSCLC adj (Dx+)
atezolizumab (RG7446) + abraxane TNBC
atezolizumab (RG7446) MIBC adj
lebrikizumab (RG3637) COPD
VEGF/ANG2 biMAb(RG7716) wAMD
ipatasertib (RG7440) solid tumors
polatuzumab vedotin (RG7596)
heme tumors
emactuzumab (RG7155)
PVNS and solid tumors
vanucizumab (RG7221)
colorectal cancer
SERD (RG6046) ER+(HER2-neg) mBC
taselisib ( RG7604) NSCLC sq 2L
taselisib ( RG7604) ER+(HER2-neg) BC neoadj
idasanutlin
AML
2015 2018 and beyond
✓ Indicates submission to health authorities has occurred
* Approved in EU
Unless stated otherwise, submissions are planned to occur in US and EU.
Submissions of additional indications for
existing products
Projects currently in phase II and III
77
Actemra systemic sclerosis
Perjeta + Heceptin HER2-pos. BC adj.
Perjeta+Herceptin
HER2-pos. gastric cancer 1L
Kadcyla
HER2-pos. BC adj.
Actemra giant cell arteritis
2016
Avastin (US)
GBM
Gazyva DLBCL 1L
Gazyva
iNHL rituximab-ref. ✓
Gazyva follicular lymphoma 1L
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
Perjeta + Herceptin
HER2-pos. mBC 2L
Avastin +Tarceva (EU) ✓
EGFR mut+ NSCLC
Avastin rel. ovarian ca. Pt-sens.*
Kadcyla+Perjeta
HER2-pos. BC adj.
Kadcyla+Perjeta
HER2-pos. BC neoadj.
Kadcyla
HER2-pos. NSCLC
2017
Zelboraf
melanoma adj.
MabThera pemphigus vulgaris
ranibizumab PDS (US) wAMD
Alecensa (alectinib)1L Alk+ NSCLC
obinutuzumab
lupus nephritis
Status as of January 28, 2016
Major granted and pending approvals 2015
78
Neuroscience
Ophthalmology
Other
NME
Oncology
Immunology
Infectious Diseases
CardioMetabolism
EU
US
Approved Pending approvals
Avastin cervical cancer
April 2015
Perjeta HER2+ BC neoadj.
July 2015
Cotellic + Zelboraf
m. melanoma
November 2015
MabThera SC CLL
Filed November 2014
Cotellic + Zelboraf
m. melanoma
November 2015
Lucentis diabetic retinopathy
February 2015
Status as of January 28, 2016
Japan-Chugai Xeloda gastric cancer adj.
November 2015
Bonviva osteoporosis (oral)
January 2016
Avastin + Tarceva EGFR mut+ NSCLC
Filed July 2015
Alecensa (alectinib)
ALK+ NSCLC 2L
Filed September 2015
Alecensa (alectinib)
ALK+ NSCLC 2L
December 2015
Gazyva iNHL rituximab-ref. Filed August 2015
Gazyva iNHL rituximab-ref.
Filed September 2015
Avastin
cervical cancer
Filed September 2015
atezolizumab
bladder cancer 2L
Filed January 2016
venetoclax
CLL rel/ref
Filed October 2015
venetoclax + Rituxan FL rel/ref TNBC
Roche Group Development pipeline
Combinations
79
Phase III
(12 AIs)
atezo+Zelboraf+/-Cotellic melanoma
atezo+Avastin+chemo solid tumors
atezo+Tarceva/ Alecensa NSCLC
atezolizumab +Cotellic solid tumors
atezolizumab +ipi/IFN solid tumors
RG7446
RG7446
RG7446
RG7446
RG7446
CD40 MAb+atezolizumab s. tumors RG7876
atezolizumab+Gazyva lymphoma RG7446
emactuzumab + atezolizumab s.tumors RG7155
atezolizumab+Avastin RCC RG7446
atezo+chemo NSCLC non-sq. 1L RG7446
NSC atezo+chemo+Avastin NSCLC non-sq. 1L RG7446
atezolizumab+chemo NSCLC sq. 1L RG7446
New Molecular Entity (NME) Additional Indication (AI)
Oncology
Immunology
RG-No Roche Genentech managed
OX40 MAb + atezolizumab s. tumors RG7888
atezo+lenalidomide multiple myeloma RG7446
atezolizumab+abraxane TNBC RG7446
CEA IL2v FP+atezolizumab s. tumors RG7813
IDO inh + atezolizumab solid tumors RG6078
venetoclax+Gazyva CLL
ERK inh + Cotellic solid tumors
RG7601
RG7842
duligotuzumab+Cotellic solid tumors RG7597
Cotellic+paclitaxel TNBC RG7421
lebrikizumab +/- Esbriet IPF
RG7601
RG3637
Perjeta+Herceptin HER2+gastric ca 1L RG1273
Perjeta+Herceptin HER2+ mBC 2L RG1273
venetoclax+Rituxan CLL rel/ref RG7601
Kadcyla + Perjeta HER2+ BC adj RG3502
Kadcyla + Perjeta HER2+ BC neoadj RG3502
Perjeta+Herceptin HER2+ BC adj RG1273
venetoclax+Gazyva CLL 1L RG7601
Avastin+Tarceva EGFR mut+ NSCLC RG4351
1 EU only
Phase I
(5 NMEs + 14 AIs)
Phase II
(3 Als)
Registration
(1 AI)
atezolizumab + K/ H+P HER2+BC RG7446
CEA CD3 TCB+atezolizumab s. tumors RG7802
Status as of January 28, 2016
Erivedge+Esbriet IPF RG3616*
Gazyva multiple combos heme indications RG7159
Cancer immunotherapy pipeline overview
80
Phase I
(7 NMEs+16 AIs)
Phase II
(1 NME + 1 Al)
Phase III
(10 AIs)
atezo+Avastin+chemo solid tumors
atezo+Tarceva NSCLC EGFR+
atezolizumab +Cotellic solid tumors
atezolizumab solid tumors
atezolizumab +ipi/IFN solid tumors
OX40 MAb solid tumors
RG7446
RG7446
RG7446
RG7446
RG7446
RG7888
CEA CD3 TCB + atezolizumab s. tumors RG7802
CD40 MAb+atezolizumab solid tumors RG7876
atezolizumab+Gazyva lymphoma RG7446
emactuzumab + atezolizumab s.tumors RG7155
IDO inh solid tumors RG6078
atezolizumab+Avastin RCC RG7446
atezolizumab NSCLC 2/3L RG7446
emactuzumab PVNS/solid tumors RG7155 atezolizumab bladder cancer 2L RG7446
atezolizumab NSCLC 2L RG7446
atezo+chemo NSCLC non-sq. 1L RG7446
NSC atezo+chemo+Avastin NSCLC non-sq. 1L RG7446
atezolizumab+chemo NSCLC sq. 1L RG7446
atezolizumab Dx+ NSCLC sq. 1L RG7446
atezolizumab Dx+ NSCLC non-sq. 1L RG7446
atezolizumab + IDO inh solid tumors *INCB
atezolizumab +varlilumab solid tumors *CDX
New Molecular Entity (NME) Additional Indication (AI)
Oncology
RG-No Roche Genentech managed
OX40 MAb + atezolizumab solid tumors RG7888
atezo+lenalidomide multiple myeloma RG7446
atezolizumab+abraxane TNBC RG7446
atezolizumab Dx+ NSCLC adj RG7446
atezolizumab muscle inv. bladder ca adj RG7446
CEA IL2v FP+atezolizumab solid tumors RG7813
IDO inh + atezolizumab solid tumors RG6078
CD20/CD3 biMAb hem tumors RG7828
Registration
(1 NME)
FAP IL2v FP solid tumors RG7461
Status as of January 28, 2016
atezo+Zelboraf+/-Cotellic m. melanoma RG7446
atezolizumab + K/HP HER2+ BC RG7446
* External collaborations: INCB- Incyte INCB024360,
CDX-1127- Celldex CD27 MAb; CO – Clovis CO-1686
CPI – Corvus CPI-444
atezo+rociletinib EGFRmut+ NSCLC *CO
atezo+A2Ai solid tumors *CPI
Doing now what patients need next